Job Title: Engineering - Senior Engineer, Process Engineering
Location: Tempe, AZ
Duration: 12+ Months Contract
Job Description:
Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Client new product development procedures.
· Ensure quality of process and product as defined in the appropriate operation and material specifications.
· Assist in the selection and design of equipment based on analysis of specifications, reliability, and regulatory requirements.
· Support capital acquisition activities, including specifying equipment, contract negotiation, installation, and validation.
· Write operations manuals, troubleshooting manuals, continuous and preventive maintenance manuals
· Analyze equipment to establish operating data and conduct experimental test and result analysis.
· Use engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines and product costs.
· Participate in process review meetings.
· Participate in process failure mode and effect analysis (PFMEA), control plan, standard operating procedures (SOP) and production part approval process (PPAP) generation associated with product transfers and launches.
· Complete capability studies for in-process inspection and generate subsequent inspection documentation.
· Conduct qualifications, validations, and measurement system analysis (MSA) studies for new products and new processes. Review and approve validation documentation.
· Work in a hands-on manner at the manufacturing site to support the implementation of new processes as specified in development.
· Drive and execute effective communication with all stakeholders to enable project success.
· Provide training for manufacturing team members.
· Ensure adherence to GMP and safety procedures
Must have:-
· 2+ years of relevant work experience
· Knowledge of manufacturing processes, materials, product, and process design
· Experience with user requirement specifications (URS), process failure mode and effect analysis (PFMEA), standard operating procedures (SOP)
Nice to have:-
· Experience writing and executing validations
· Good understanding of design for manufacturing (DFM), related statistical tools, and validation/verification techniques
· Experience in new product introduction or manufacturing engineering
· Experience in an FDA regulated or regulated industry
Qualification:-
2+ years of relevant work experience
Bachelor’s degree in engineering Bachelor's degree in Industrial or Systems Engineering – highly preferred Lean Six Sigma Green Belt Certification or above – preferred
Engineering - Senior Engineer, Process Engineering • Guadalupe, AZ
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